Regulatory Affairs CMC Manager (SPPM)

24 Apr, 2022


Regulatory Affairs CMC Manager (SPPM)

Thousands Oaks, CA

Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC, Devices, & Biosimilar Regulatory Affairs.  SPPM’s mission is to enable the productivity and achievement of department staff and stakeholders by:

  • Driving continuous improvement of processes and tools to enable success of programs and staff;
  • Creating awareness and connecting stakeholders with key information and each other; and
  • Shaping the training strategy across the organization, both internal and external to the department.

The Manager in SPPM will support the new hire onboarding program, facilitate training on process and procedures, and support process development and continuous improvement.

Additional job responsibilities of the SPPM Manager include:

  • Facilitate communication across Global CMC, Devices, & Biosimilar Regulatory Affairs to ensure process robustness and awareness
  • Drive consistency across Global CMC, Devices, & Biosimilar Regulatory Affairs
  • Develop and maintain training materials Global CMC, Devices, & Biosimilar Regulatory Affairs
  • Train staff on select departmental processes and procedures
  • Ensure consistent use of processes and tools across department
  • Continuous improvement of templates for presentations, timelines, trackers, and other tools
  • Liaise with functions in GRAAS and Operations to ensure alignment
  • Participate in cross-functional special project teams

Learn more here

Job posted: 2022-04-24